Given intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks)

Other Name: Paraplatin

Drug: Pemetrexed

Given intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks)

Other Name: Alimta

Detailed Description:

Before patients receive any chemotherapy treatments they will be given three medications to prevent side effects from the chemotherapy drugs. These medications are vitamin B12, folic acid and dexamethasone.

Chemotherapy treatments will be given intravenously in the outpatient clinic. Pemetrexed will be given first and will take 10 minutes to infuse followed by carboplatin which will take 30-45 minutes to infuse. These treatments will be repeated once every three weeks for 6 cycles of chemotherapy (18 weeks).

Before each chemotherapy treatment the following tests and procedures will be performed: physical exam and medical history; evaluation of ability to undertake daily activities; and blood tests.

After every 2 cycles of chemotherapy (every 6 weeks) patients will have a CT or MRI scan to measure how well their cancer is responding to treatment.

The study treatment will last for 6 cycles of chemotherapy as long as the tumor does not grow and the patient isn't experiencing any severe side effects.

The following histologic subtypes are eligible: papillary serous, endometrioid, mucinous, clear cell, adenocarcinomas, transitional, and mixtures of the above.

At least one measurable lesion according to RECIST criteria via CT or MRI scan

Received a platinum-containing regimen at initial diagnosis

ECOG performance status of 0,1 or 2

18 years of age or older

Life expectancy of greater than 12 weeks

WBC > 1,500/mm3

Neutrophils > 1,500/mm3

Platelets > 100,000/mm3

Total Bilirubin < 1.5 ULN

Calculated creatinine clearance > 45 ml/min

ALT/AST < 3 x ULN (no liver mets) ALT/AST < 5 x ULN (with liver mets)

Complete recovery from completion of previous chemotherapy or biologic therapy

Negative pregnancy test and agree to practice effective method of birth control

Exclusion Criteria:

Patients with sarcomatous, stromal, or germ cell elements

Prior pelvic radiotherapy > 25% of bone marrow

Uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs

Past history of bone marrow transplantation or stem cell support

Known history of CNS metastasis unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants

Prior malignancy except adequately treated carcinoma in situ of the uterine cervix, incidental stage I endometrial cancer, basal cell or squamous cell skin cancer or breast cancer (invasive or ductal carcinoma in situ) of which the patient has been disease-free for at least five years

Routine prophylactic use of G-CSF or GM-CSF or blood transfusions within 2 weeks

Clinically significant cardiac disease as defined by: history of unstable angina within 6 months; history of symptomatic ventricular arrhythmias; history of congestive heart failure; history of myocardial infarction within 6 months

Uncontrolled hypercalcemia or diabetes mellitus

Any signs of intestinal obstruction with bowel function and/or nutrition

Grade 2 or greater peripheral neuropathy

Participation in an investigational study within three weeks

History of anaphylactic shock to prior platinum chemotherapy

History of psychiatric disability or other central nervous system disorder

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230542